Research ArticleResearch
Artificial Leaks in Container Closure Integrity Testing: Nonlinear Finite Element Simulation of Aperture Size Originated by a Copper Wire Sandwiched between the Stopper and the Glass Vial
Alejandra Nieto, Holger Roehl, Helen Brown, Michael Adler, Pascal Chalus and Hanns-Christian Mahler
PDA Journal of Pharmaceutical Science and Technology July 2016, 70 (4) 313-324; DOI: https://doi.org/10.5731/pdajpst.2015.006080
Alejandra Nieto
1Late-Stage Pharmaceutical and Process Development—Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
Holger Roehl
1Late-Stage Pharmaceutical and Process Development—Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
Helen Brown
1Late-Stage Pharmaceutical and Process Development—Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
Michael Adler
1Late-Stage Pharmaceutical and Process Development—Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
Pascal Chalus
2Solid State Properties Analytics—Pharmaceutical Technical Development, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
Hanns-Christian Mahler
1Late-Stage Pharmaceutical and Process Development—Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
3Lonza AG, Drug Product Services, Basel, Switzerland

References
- 1.↵U.S. Pharmacopoeia. USP <1207> Sterile Product Packaging—Integrity Evaluation. In U.S. Pharmacopoeia—National Formulary; United States Pharmacopoeial Convention, Inc.: Rockville, MD, 2011.
- 2.↵FDA Guidance for Industry. Container Closure Systems for Packaging Human Drugs and Biologics, 1999.
- 3.↵European Pharmacopoeia. Section 5.1.1. Methods of Preparation of Sterile Products. In European Pharmacopoeia, 8th ed.; European Directorate for the Quality of Medicines: Strasbourg, France, 2016.
- 4.↵FDA Guidance for Industry. Container and Closure Integrity Testing in Lieu of Sterility Testing as Component of the Stability Protocol for Sterile Products, U.S. Department of Health and Human Services Food and Drug Administration, 2008.
- 5.↵
- Burrell L. S.,
- Carver M. W.,
- DeMuth G. E.,
- Lambert W. J.
- 6.↵
- White E. K.
- 7.↵
- Morrical B. D.,
- Goverde M.,
- Grausse J.,
- Gerwig T.,
- Vorgrimler L.,
- Morgen R.,
- Buettiker J. P.
- 8.↵
- Guazzo D.
- 9.↵
- Wolf H.,
- Stauffer T.,
- Chen S. C.,
- Lee Y.,
- Forster R.,
- Ludzinski M.,
- Kamat M.,
- Godorov P.,
- Guazzo D. M.
- 10.↵
- Yoon S-Y.,
- Sagi H.,
- Goldhammer C.,
- Li L.
- 11.↵
- Keller S. W.
- 12.↵
- Kirsch L. E.,
- Nguyen L.,
- Moeckly C. S.
- 13.↵
- Kirsch L. E,
- Nguyen L.,
- Moeckly C. S.,
- Gerth R.
- 14.↵
- Yam K.
- 15.↵
- Li L.
- 16.↵
- 17.↵
- Mathaes R.,
- Mahler H. C.,
- Buettiker J. P.,
- Roehl H.,
- Lam P.,
- Brown H.,
- Luemkemann J.,
- Adler M.,
- Huwyler J.,
- Streubel A.,
- Mohl S.
- 18.↵
- Mathaes R.,
- Mahler H. C.,
- Roggo Y.,
- Ovadia R.,
- Lam P.,
- Stauch O.,
- Vogt M.,
- Huwyler J.,
- Mohl S.,
- Streubel A.
- 19.↵
- Denyer P.,
- Baird R. M.
- Kirsch L. E.
- 20.↵
- Slaughter W. S.
- 21.↵
- Taliercio A.
- 22.↵
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 4
July/August 2016
Artificial Leaks in Container Closure Integrity Testing: Nonlinear Finite Element Simulation of Aperture Size Originated by a Copper Wire Sandwiched between the Stopper and the Glass Vial
Alejandra Nieto, Holger Roehl, Helen Brown, Michael Adler, Pascal Chalus, Hanns-Christian Mahler
PDA Journal of Pharmaceutical Science and Technology Jul 2016, 70 (4) 313-324; DOI: 10.5731/pdajpst.2015.006080
Artificial Leaks in Container Closure Integrity Testing: Nonlinear Finite Element Simulation of Aperture Size Originated by a Copper Wire Sandwiched between the Stopper and the Glass Vial
Alejandra Nieto, Holger Roehl, Helen Brown, Michael Adler, Pascal Chalus, Hanns-Christian Mahler
PDA Journal of Pharmaceutical Science and Technology Jul 2016, 70 (4) 313-324; DOI: 10.5731/pdajpst.2015.006080
Jump to section
Related Articles
- No related articles found.
Cited By...
- A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
- Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
- Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies
- Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers
- Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy
- Container Closure Integrity Testing--Practical Aspects and Approaches in the Pharmaceutical Industry